BCIRG-001 研究 10 年随访时乳腺癌放疗对女性心脏疾病的影响。
Effect of Breast Irradiation on Cardiac Disease in Women Enrolled in BCIRG-001 at 10-Year Follow-Up.
机构信息
Department of Radiation Oncology, Perlmutter Cancer Center, New York University School of Medicine, New York, New York.
Department of Radiation Oncology, Perlmutter Cancer Center, New York University School of Medicine, New York, New York.
出版信息
Int J Radiat Oncol Biol Phys. 2017 Nov 1;99(3):541-548. doi: 10.1016/j.ijrobp.2017.06.018. Epub 2017 Jun 23.
PURPOSE
To investigate cardiac toxicity associated with breast radiation therapy (RT) at 10-year follow-up in BCIRG-001, a phase 3 trial comparing adjuvant anthracycline chemotherapy (fluorouracil, doxorubicin, and cyclophosphamide) with anthracycline-taxane chemotherapy (docetaxel, doxorubicin, and cyclophosphamide) in women with lymph node-positive early breast cancer.
METHODS AND MATERIALS
Prospective data from all 746 patients in the control arm (fluorouracil, doxorubicin, and cyclophosphamide) of BCIRG-001 at 10-year follow-up were obtained from Project Data Sphere. Cardiac toxicities examined included myocardial infarction (MI), heart failure (HF), arrhythmias, and relative and absolute left ventricular ejection fraction decrease of >20% from baseline. Toxicities were compared between patients who received RT versus no RT, left-sided RT versus no RT, and internal mammary nodal RT versus no RT.
RESULTS
Of the 746 patients, 559 (75%) received RT to a median dose of 50 Gy. Myocardial infarction occurred in 3 RT patients (0.5%) versus 6 no-RT patients (3%) (P=.01). Heart failure was seen in 15 RT patients (2.7%) versus 3 no-RT patients (1.6%) (P=.6). Among these, 35 RT patients (18%) had a left ventricular ejection fraction relative decrease of >20% baseline versus 7 (10%) who did not receive RT (P=.1). Arrhythmias were more common in RT patients (3.2%) versus no-RT patients (0%) (P=.01). On univariable and multivariable analysis HF was not significantly associated with RT, and MI was negatively associated with RT.
CONCLUSIONS
In this retrospective analysis of prospective toxicity outcomes, there is an increased risk of arrhythmias but no clear evidence of significantly increased risk of MI or HF at 10 years in lymph node-positive women treated with breast RT and uniform adjuvant doxorubicin-based chemotherapy. Given the low incidence of these outcomes, studies with larger numbers are needed to confirm our findings.
目的
在 BCIRG-001 中研究与乳腺癌放射治疗（RT）相关的心脏毒性，这是一项比较辅助蒽环类化疗（氟尿嘧啶、多柔比星和环磷酰胺）与蒽环类-紫杉类化疗（多西紫杉醇、多柔比星和环磷酰胺）的 3 期试验，入组了淋巴结阳性早期乳腺癌患者。
方法和材料
通过项目数据球（Project Data Sphere）获取 BCIRG-001 对照组（氟尿嘧啶、多柔比星和环磷酰胺）的 746 例患者的 10 年随访前瞻性数据。检查的心脏毒性包括心肌梗死（MI）、心力衰竭（HF）、心律失常以及与基线相比左心室射血分数下降超过 20%的相对和绝对下降。比较了接受 RT 与未接受 RT、左侧 RT 与未接受 RT、内乳淋巴结 RT 与未接受 RT的患者之间的毒性。
结果
在 746 例患者中，559 例（75%）接受了中位剂量为 50Gy 的 RT。3 例 RT 患者（0.5%）发生 MI，6 例未接受 RT 患者（3%）发生 MI（P=.01）。15 例 RT 患者（2.7%）发生心力衰竭，3 例未接受 RT 患者（1.6%）发生心力衰竭（P=.6）。其中，35 例 RT 患者（18%）的左心室射血分数相对下降超过 20%基线，7 例（10%）未接受 RT（P=.1）。心律失常在 RT 患者中更为常见（3.2%），而未接受 RT 患者中则为 0%（P=.01）。单变量和多变量分析均显示 HF 与 RT 无显著相关性，而 MI 与 RT 呈负相关。
结论
在这项前瞻性毒性结果的回顾性分析中，淋巴结阳性接受乳房 RT 和统一辅助多柔比星为基础的化疗的女性，在 10 年时心律失常风险增加，但 MI 或 HF 的风险无明显增加。考虑到这些结果的发生率较低，需要更大数量的研究来证实我们的发现。
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